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Personalised reprogramming to prevent progressive pacemaker-related left ventricular dysfunction: A phase II randomised, controlled clinical trial

BACKGROUND: Pacemakers are widely utilised to treat bradycardia, but right ventricular (RV) pacing is associated with heightened risk of left ventricular (LV) systolic dysfunction and heart failure. We aimed to compare personalised pacemaker reprogramming to avoid RV pacing with usual care on echoca...

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Autores principales: Paton, Maria F., Gierula, John, Lowry, Judith E., Cairns, David A., Bose Rosling, Kieran, Cole, Charlotte A., McGinlay, Melanie, Straw, Sam, Byrom, Rowena, Cubbon, Richard M., Kearney, Mark T., Witte, Klaus K.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8668131/
https://www.ncbi.nlm.nih.gov/pubmed/34898655
http://dx.doi.org/10.1371/journal.pone.0259450
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author Paton, Maria F.
Gierula, John
Lowry, Judith E.
Cairns, David A.
Bose Rosling, Kieran
Cole, Charlotte A.
McGinlay, Melanie
Straw, Sam
Byrom, Rowena
Cubbon, Richard M.
Kearney, Mark T.
Witte, Klaus K.
author_facet Paton, Maria F.
Gierula, John
Lowry, Judith E.
Cairns, David A.
Bose Rosling, Kieran
Cole, Charlotte A.
McGinlay, Melanie
Straw, Sam
Byrom, Rowena
Cubbon, Richard M.
Kearney, Mark T.
Witte, Klaus K.
author_sort Paton, Maria F.
collection PubMed
description BACKGROUND: Pacemakers are widely utilised to treat bradycardia, but right ventricular (RV) pacing is associated with heightened risk of left ventricular (LV) systolic dysfunction and heart failure. We aimed to compare personalised pacemaker reprogramming to avoid RV pacing with usual care on echocardiographic and patient-orientated outcomes. METHODS: A prospective phase II randomised, double-blind, parallel-group trial in 100 patients with a pacemaker implanted for indications other than third degree heart block for ≥2 years. Personalised pacemaker reprogramming was guided by a published protocol. Primary outcome was change in LV ejection fraction on echocardiography after 6 months. Secondary outcomes included LV remodeling, quality of life, and battery longevity. RESULTS: Clinical and pacemaker variables were similar between groups. The mean age (SD) of participants was 76 (+/-9) years and 71% were male. Nine patients withdrew due to concurrent illness, leaving 91 patients in the intention-to-treat analysis. At 6 months, personalised programming compared to usual care, reduced RV pacing (-6.5±1.8% versus -0.21±1.7%; p<0.01), improved LV function (LV ejection fraction +3.09% [95% confidence interval (CI) 0.48 to 5.70%; p = 0.02]) and LV dimensions (LV end systolic volume indexed to body surface area -2.99mL/m(2) [95% CI -5.69 to -0.29; p = 0.03]). Intervention also preserved battery longevity by approximately 5 months (+0.38 years [95% CI 0.14 to 0.62; p<0.01)) with no evidence of an effect on quality of life (+0.19, [95% CI -0.25 to 0.62; p = 0.402]). CONCLUSIONS: Personalised programming in patients with pacemakers for bradycardia can improve LV function and size, extend battery longevity, and is safe and acceptable to patients. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03627585.
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spelling pubmed-86681312021-12-14 Personalised reprogramming to prevent progressive pacemaker-related left ventricular dysfunction: A phase II randomised, controlled clinical trial Paton, Maria F. Gierula, John Lowry, Judith E. Cairns, David A. Bose Rosling, Kieran Cole, Charlotte A. McGinlay, Melanie Straw, Sam Byrom, Rowena Cubbon, Richard M. Kearney, Mark T. Witte, Klaus K. PLoS One Research Article BACKGROUND: Pacemakers are widely utilised to treat bradycardia, but right ventricular (RV) pacing is associated with heightened risk of left ventricular (LV) systolic dysfunction and heart failure. We aimed to compare personalised pacemaker reprogramming to avoid RV pacing with usual care on echocardiographic and patient-orientated outcomes. METHODS: A prospective phase II randomised, double-blind, parallel-group trial in 100 patients with a pacemaker implanted for indications other than third degree heart block for ≥2 years. Personalised pacemaker reprogramming was guided by a published protocol. Primary outcome was change in LV ejection fraction on echocardiography after 6 months. Secondary outcomes included LV remodeling, quality of life, and battery longevity. RESULTS: Clinical and pacemaker variables were similar between groups. The mean age (SD) of participants was 76 (+/-9) years and 71% were male. Nine patients withdrew due to concurrent illness, leaving 91 patients in the intention-to-treat analysis. At 6 months, personalised programming compared to usual care, reduced RV pacing (-6.5±1.8% versus -0.21±1.7%; p<0.01), improved LV function (LV ejection fraction +3.09% [95% confidence interval (CI) 0.48 to 5.70%; p = 0.02]) and LV dimensions (LV end systolic volume indexed to body surface area -2.99mL/m(2) [95% CI -5.69 to -0.29; p = 0.03]). Intervention also preserved battery longevity by approximately 5 months (+0.38 years [95% CI 0.14 to 0.62; p<0.01)) with no evidence of an effect on quality of life (+0.19, [95% CI -0.25 to 0.62; p = 0.402]). CONCLUSIONS: Personalised programming in patients with pacemakers for bradycardia can improve LV function and size, extend battery longevity, and is safe and acceptable to patients. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03627585. Public Library of Science 2021-12-13 /pmc/articles/PMC8668131/ /pubmed/34898655 http://dx.doi.org/10.1371/journal.pone.0259450 Text en © 2021 Paton et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Paton, Maria F.
Gierula, John
Lowry, Judith E.
Cairns, David A.
Bose Rosling, Kieran
Cole, Charlotte A.
McGinlay, Melanie
Straw, Sam
Byrom, Rowena
Cubbon, Richard M.
Kearney, Mark T.
Witte, Klaus K.
Personalised reprogramming to prevent progressive pacemaker-related left ventricular dysfunction: A phase II randomised, controlled clinical trial
title Personalised reprogramming to prevent progressive pacemaker-related left ventricular dysfunction: A phase II randomised, controlled clinical trial
title_full Personalised reprogramming to prevent progressive pacemaker-related left ventricular dysfunction: A phase II randomised, controlled clinical trial
title_fullStr Personalised reprogramming to prevent progressive pacemaker-related left ventricular dysfunction: A phase II randomised, controlled clinical trial
title_full_unstemmed Personalised reprogramming to prevent progressive pacemaker-related left ventricular dysfunction: A phase II randomised, controlled clinical trial
title_short Personalised reprogramming to prevent progressive pacemaker-related left ventricular dysfunction: A phase II randomised, controlled clinical trial
title_sort personalised reprogramming to prevent progressive pacemaker-related left ventricular dysfunction: a phase ii randomised, controlled clinical trial
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8668131/
https://www.ncbi.nlm.nih.gov/pubmed/34898655
http://dx.doi.org/10.1371/journal.pone.0259450
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